A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery (PEARL)

Astellas

Status and phase: Completed; Phase 2

Conditions: Arthroplasty, Replacement, Knee

Treatments: Drug: YM150; Drug: Warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00595426

150-CL-033

Details and patient eligibility

About

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Enrollment: 685 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is scheduled for elective primary knee arthroplasty
• Written Informed consent obtained

Exclusion criteria

• Subject has documented history of previous VTE
• Subject is considered to be at increased risk of VTE
• Subject has active bleeding or any condition associated with increased risk of bleeding
• Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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685 participants in 5 patient groups

1. YM150 Dose X, twice daily

Experimental group

Treatment:

Drug: YM150

2. YM150 Dose Y, once daily

Experimental group

Treatment:

Drug: YM150

3. YM150 Dose Y, twice daily

Experimental group

Treatment:

Drug: YM150

4. YM150 Dose Z, once daily

Experimental group

Treatment:

Drug: YM150

5. Warfarin

Active Comparator group

Description:

various doses

Treatment:

Drug: Warfarin